Reduction of Breast Enlargement Using the Da Vinci Xi Robot

Not Applicable

• Conditions: Breast Hypertrophy
• Interventions: Procedure: Robot Breast reduction surgery

• Registration Number: NCT04597515
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove.

The expected result is to achieve a reduction in breast enlargement with no visible scar using Da Da Vinci Xi robot.

Detailed Description

Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloid scarring, especially in young women.

The current research project is based on the hypothesis that the same technique could be used in the context of a reduction of breast enlargement on a smaller surface allowing the determination of a perimammary "halo" of scar retraction. The project consists in removing a breast disc at the base, thus causing a sagging skin cut of 2 to 3 cm but this time, circular.

The expected result is to achieve a reduction in breast enlargement with no visible scar, using Da Vinci Xi robot.

Study Timeline

• Study First Submitted: 2020-06-02
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-16
• Last Update Submitted: 2020-10-16
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Study Start: 2020-11-01
• Primary Completion: 2021-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

• Women over the age of 18
• Category 1 or 2 according to the classification of Regnault
• Breast size cup c or more
• Areola "looking in front", ie a distance between point A (at noon at the top of the areola) at the mid-sternal point of about 16 cm to 24 cm
• Ptosis (distance between the lowest part of the breast and the furrow under the breast) to a maximum of 7cm (measurement in sitting position)
• Expected correction of ptosis by half with reduction of 1 to 3 cup sizes
• Good quality thick skin
• Affiliated patient or beneficiary of a social security scheme
• Patient requesting breast reduction
• Patient who signed free and informed consent

Exclusion Criteria

• Areola "look down"; point A more than 25 cm
• Ptose greater than and equal to 8 cm
• Thin skin
• Smoker
• Patient on anti-coagulant
• Patient participating in another clinical study
• Protected patient: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision;
• Pregnant, lactating woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot Reduction	Robot Breast reduction surgery	The project consists in removing a breast disc at the base, causing a circular sagging skin cut of 2 to 3 cm .

Primary Outcome Measures

Name	Time	Method
Number of Visible Scare	3 months	The main judgment criterion for the scar balance will be a photograph of the breasts at 3 months to describe the number of visible scars. Aspect and position.

Secondary Outcome Measures

Name	Time	Method
Intensity of Back Pain	3 months	The pain score on the EVA scale (score from 0 no pain to 10 max pain) will be described
Efficacity of the reduction (weight)	day of surgery	- The weight of the exeresis (more than 300g per side which corresponds according to calculation to a gland disc about 2 cm thick on an extended conical breast of 13cm for the base)
Skin retraction	at 3 months	- Post-operative skin retraction

Trial Locations

Locations (1)

Hôpital Privé d'Antony; 🇫🇷 Antony, IDF, France